# K111021: Cubescan / Biocon-700

- Pathway: 510(k) (Traditional)
- Applicant: Mcube Technology Co., Ltd.
- Decided: Apr 27, 2011 after 15 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K915436 (1992). 8 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071217: Bladderscan Bvi 9400 Ultrasound, Verathon Incorporated (2007) Summary page 1.
- K091518: Cubescan Biocon-500 Diagnostic Ultrasound System, Mcube Technology Co., Ltd. (2009) Summary page 1.

## Most influential descendants
- K131227: Padscan HD Series Bladder Scanner (2013), 7 descendants of its own
- K171591: CUBEScan™ BioCon-900 (Bladder Volume Measurement System) (2017), 4 descendants of its own
- K190769: Bladder Scanner (Models: M2, M2-W, M1, M1-W) (2019), 3 descendants of its own
- K201316: Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) (2021), 2 descendants of its own
- K200548: CUBEScan BioCon-1100 (2020), 2 descendants of its own

## Indications for use
The BioCon-700 is a B-mode pulsed-echo ultrasound device. The BioCon-700 is intended as a portable battery-operated device. The BioCon-700 brojects ultrasonic energy through the abdomen of the patient obtaining images of the bladder in order to calculate the urine volume non-invasively. BioCon-700 is intended to be used by a qualified medical professional to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-700 are fetal use and use on pregnant patients.

Source page: https://510kreport.com/device/K111021
Methodology: https://510kreport.com/methodology